Application 202871

Type: ANDA
Sponsor: ALEMBIC PHARMS LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	METOPROLOL TARTRATE	METOPROLOL TARTRATE	TABLET;ORAL	25MG	No	No
002	METOPROLOL TARTRATE	METOPROLOL TARTRATE	TABLET;ORAL	50MG	No	No
003	METOPROLOL TARTRATE	METOPROLOL TARTRATE	TABLET;ORAL	100MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A202871-001	METOPROLOL TARTRATE	METOPROLOL TARTRATE	25MG	TABLET / ORAL	AB	2013-05-28
A202871-002	METOPROLOL TARTRATE	METOPROLOL TARTRATE	50MG	TABLET / ORAL	AB	2013-05-28
A202871-003	METOPROLOL TARTRATE	METOPROLOL TARTRATE	100MG	TABLET / ORAL	AB	2013-05-28

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A202871-001	AB
A202871-002	AB
A202871-003	AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A202871-001	METOPROLOL TARTRATE	25MG	TABLET / ORAL	AB	2013-05-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202871-002	METOPROLOL TARTRATE	50MG	TABLET / ORAL	AB	2013-05-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202871-003	METOPROLOL TARTRATE	100MG	TABLET / ORAL	AB	2013-05-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202871-001	METOPROLOL TARTRATE	25MG	TABLET / ORAL	AB	2013-05-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202871-002	METOPROLOL TARTRATE	50MG	TABLET / ORAL	AB	2013-05-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202871-003	METOPROLOL TARTRATE	100MG	TABLET / ORAL	AB	2013-05-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202871-001	METOPROLOL TARTRATE	25MG	TABLET / ORAL	AB	2013-05-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202871-002	METOPROLOL TARTRATE	50MG	TABLET / ORAL	AB	2013-05-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202871-003	METOPROLOL TARTRATE	100MG	TABLET / ORAL	AB	2013-05-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202871-001	METOPROLOL TARTRATE	25MG	TABLET / ORAL	AB	2013-05-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202871-002	METOPROLOL TARTRATE	50MG	TABLET / ORAL	AB	2013-05-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202871-003	METOPROLOL TARTRATE	100MG	TABLET / ORAL	AB	2013-05-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202871-001	METOPROLOL TARTRATE	25MG	TABLET / ORAL	AB	2013-05-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202871-002	METOPROLOL TARTRATE	50MG	TABLET / ORAL	AB	2013-05-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202871-003	METOPROLOL TARTRATE	100MG	TABLET / ORAL	AB	2013-05-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202871-001	METOPROLOL TARTRATE	25MG	TABLET / ORAL	AB	2013-05-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202871-002	METOPROLOL TARTRATE	50MG	TABLET / ORAL	AB	2013-05-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202871-003	METOPROLOL TARTRATE	100MG	TABLET / ORAL	AB	2013-05-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202871-001	METOPROLOL TARTRATE	25MG	TABLET / ORAL	AB	2013-05-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202871-002	METOPROLOL TARTRATE	50MG	TABLET / ORAL	AB	2013-05-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202871-003	METOPROLOL TARTRATE	100MG	TABLET / ORAL	AB	2013-05-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202871-001	METOPROLOL TARTRATE	25MG	TABLET / ORAL	AB	2013-05-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202871-002	METOPROLOL TARTRATE	50MG	TABLET / ORAL	AB	2013-05-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202871-003	METOPROLOL TARTRATE	100MG	TABLET / ORAL	AB	2013-05-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202871-001	METOPROLOL TARTRATE	25MG	TABLET / ORAL	AB	2013-05-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202871-002	METOPROLOL TARTRATE	50MG	TABLET / ORAL	AB	2013-05-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202871-003	METOPROLOL TARTRATE	100MG	TABLET / ORAL	AB	2013-05-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202871-001	METOPROLOL TARTRATE	25MG	TABLET / ORAL	AB	2013-05-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202871-002	METOPROLOL TARTRATE	50MG	TABLET / ORAL	AB	2013-05-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202871-003	METOPROLOL TARTRATE	100MG	TABLET / ORAL	AB	2013-05-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202871-001	METOPROLOL TARTRATE	25MG	TABLET / ORAL	AB	2013-05-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202871-002	METOPROLOL TARTRATE	50MG	TABLET / ORAL	AB	2013-05-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202871-003	METOPROLOL TARTRATE	100MG	TABLET / ORAL	AB	2013-05-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202871-001	METOPROLOL TARTRATE	25MG	TABLET / ORAL	AB	2013-05-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202871-002	METOPROLOL TARTRATE	50MG	TABLET / ORAL	AB	2013-05-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202871-003	METOPROLOL TARTRATE	100MG	TABLET / ORAL	AB	2013-05-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202871-001	METOPROLOL TARTRATE	25MG	TABLET / ORAL	AB	2013-05-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202871-002	METOPROLOL TARTRATE	50MG	TABLET / ORAL	AB	2013-05-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202871-003	METOPROLOL TARTRATE	100MG	TABLET / ORAL	AB	2013-05-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202871-001	METOPROLOL TARTRATE	25MG	TABLET / ORAL	AB	2013-05-28	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A202871-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202871-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202871-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202871-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202871-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202871-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202871-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202871-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202871-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202871-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202871-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202871-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202871-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202871-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202871-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202871-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202871-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202871-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202871-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202871-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202871-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202871-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202871-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202871-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202871-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202871-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202871-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202871-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202871-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202871-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202871-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202871-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202871-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202871-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202871-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202871-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202871-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202871-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202871-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202871-001	AB	1	`1e350fbaab3a…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 11 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
METOPROLOL TARTRATE	METOPROLOL	REMEDYREPACK INC.	58d493d3-b69c-422a-b6a8-0f8fa1e55545	2026-08-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202871 application number: ANDA202871 ndc (product): 70518-3506
METOPROLOL TARTRATE	METOPROLOL	Bryant Ranch Prepack	00940cc5-d2eb-4841-9138-de97d7b1c674	2026-07-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202871 application number: ANDA202871
METOPROLOL TARTRATE	METOPROLOL	Northwind Health Company, LLC	471ccbfe-96dd-7ab9-e063-6394a90a5bd6	2026-07-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202871 application number: ANDA202871
METOPROLOL TARTRATE	METOPROLOL	REMEDYREPACK INC.	e1c99d45-8f42-46b1-b770-14d0eb2b300a	2026-06-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202871 application number: ANDA202871
METOPROLOL TARTRATE	METOPROLOL	Coupler LLC	512711ea-a3be-6de6-e063-6394a90a9109	2026-05-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202871 application number: ANDA202871
METOPROLOL TARTRATE	METOPROLOL	Proficient Rx LP	95b95aab-0733-4189-b4c0-429a1046c534	2026-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202871 application number: ANDA202871 ndc (product): 71205-003
METOPROLOL TARTRATE	METOPROLOL	NuCare Pharmaceuticals, Inc.	47d11c0c-82dd-33b1-e063-6394a90a6a97	2026-01-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202871 application number: ANDA202871
METOPROLOL TARTRATE	METOPROLOL	Northwind Health Company, LLC	106b7a0c-af7f-2565-e063-6294a90a34e0	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202871 application number: ANDA202871
METOPROLOL TARTRATE	METOPROLOL	NCS HealthCare of KY, LLC dba Vangard Labs	c97e7527-b44e-48ca-b6be-53999bf5554b	2025-08-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202871 application number: ANDA202871 ndc (product): 0615-8421 ndc (product): 0615-8422 ndc (product): 0615-8423
METOPROLOL TARTRATE	METOPROLOL	Alembic Pharmaceuticals Inc.	24837d82-0f3f-4482-9af0-31e5f675c30f	2024-08-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202871 application number: ANDA202871 ndc (product): 62332-114 ndc (product): 62332-112 ndc (product): 62332-113
METOPROLOL TARTRATE	METOPROLOL	Alembic Pharmaceuticals Limited	cb76a73f-549a-4170-b96a-f93ed7e09464	2023-05-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202871 application number: ANDA202871 ndc (product): 46708-290 ndc (product): 46708-291 ndc (product): 46708-292

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 36 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0615-8421	METOPROLOL TARTRATE	METOPROLOL	NCS HealthCare of KY, LLC dba Vangard Labs	ANDA	Current
0615-8422	METOPROLOL TARTRATE	METOPROLOL	NCS HealthCare of KY, LLC dba Vangard Labs	ANDA	Current
0615-8423	METOPROLOL TARTRATE	METOPROLOL	NCS HealthCare of KY, LLC dba Vangard Labs	ANDA	Current
0904-6340	Metoprolol Tartrate	Metoprolol Tartrate	Major Pharmaceuticals	ANDA	Current
0904-6340	Metoprolol Tartrate	Metoprolol Tartrate	Major Pharmaceuticals	ANDA	Current
0904-6341	Metoprolol Tartrate	Metoprolol Tartrate	Major Pharmaceuticals	ANDA	Current
0904-6341	Metoprolol Tartrate	Metoprolol Tartrate	Major Pharmaceuticals	ANDA	Current
0904-6342	Metoprolol Tartrate	Metoprolol Tartrate	Major Pharmaceuticals	ANDA	Current
0904-6342	Metoprolol Tartrate	Metoprolol Tartrate	Major Pharmaceuticals	ANDA	Current
46708-112	Metoprolol Tartrate	Metoprolol Tartrate	Alembic Pharmaceuticals Limited	ANDA	Current
46708-113	Metoprolol Tartrate	Metoprolol Tartrate	Alembic Pharmaceuticals Limited	ANDA	Current
46708-114	Metoprolol Tartrate	Metoprolol Tartrate	Alembic Pharmaceuticals Limited	ANDA	Current
46708-290	METOPROLOL TARTRATE	METOPROLOL	Alembic Pharmaceuticals Limited	ANDA	Current
46708-291	METOPROLOL TARTRATE	METOPROLOL	Alembic Pharmaceuticals Limited	ANDA	Current
46708-292	METOPROLOL TARTRATE	METOPROLOL	Alembic Pharmaceuticals Limited	ANDA	Current
53808-1076	Metoprolol Tartrate	Metoprolol Tartrate	State of Florida DOH Central Pharmacy	ANDA	Current
55154-6894	Metoprolol Tartrate	Metoprolol Tartrate	Cardinal Health	ANDA	Current
55154-6894	Metoprolol Tartrate	Metoprolol Tartrate	Cardinal Health	ANDA	Current
55154-6895	Metoprolol Tartrate	Metoprolol Tartrate	Cardinal Health	ANDA	Current
55154-6895	Metoprolol Tartrate	Metoprolol Tartrate	Cardinal Health	ANDA	Current
55154-7626	Metoprolol Tartrate	Metoprolol Tartrate	Cardinal Health	ANDA	Current
55154-7626	Metoprolol Tartrate	Metoprolol Tartrate	Cardinal Health	ANDA	Current
62332-112	METOPROLOL TARTRATE	METOPROLOL	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-112	METOPROLOL TARTRATE	METOPROLOL	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-112	METOPROLOL TARTRATE	METOPROLOL	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-113	METOPROLOL TARTRATE	METOPROLOL	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-113	METOPROLOL TARTRATE	METOPROLOL	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-113	METOPROLOL TARTRATE	METOPROLOL	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-114	METOPROLOL TARTRATE	METOPROLOL	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-114	METOPROLOL TARTRATE	METOPROLOL	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-114	METOPROLOL TARTRATE	METOPROLOL	Alembic Pharmaceuticals Inc.	ANDA	Current
68151-4645	Metoprolol Tartrate	Metoprolol Tartrate	Carilion Materials Management	ANDA	Current
70518-3506	METOPROLOL TARTRATE	METOPROLOL	REMEDYREPACK INC.	ANDA	Current
71205-003	METOPROLOL TARTRATE	METOPROLOL	Proficient Rx LP	ANDA	Current
71205-003	METOPROLOL TARTRATE	METOPROLOL	Proficient Rx LP	ANDA	Current
71335-0666	METOPROLOL TARTRATE	METOPROLOL	Bryant Ranch Prepack	ANDA	Current